Date Initiated by Firm | June 27, 2018 |
Create Date | August 22, 2018 |
Recall Status1 |
Terminated 3 on April 13, 2020 |
Recall Number | Z-2884-2018 |
Recall Event ID |
80613 |
510(K)Number | K051590 |
Product Classification |
Rod, fixation, intramedullary and accessories - Product Code HSB
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Product | Stryker T2 ANKLE ARTHRODESIS NAIL RIGHT 10MMX200MM Item Number: 1819-1020S
T2 ANKLE ARTHRODESIS NAIL RIGHT 12MMX200MM 1819-1220S
T2 LONG PROXIMAL HUMERAL NAIL LEFT 240mm1832-2824S
T2 LONG PROXIMAL HUMERAL NAIL LEFT 280mm 1832-2828S
T2 LONG PROXIMAL HUMERAL NAIL RIGHT 260mm 1832-3826S
T2 Ankle Arthrd Nail lft 1818-1115S |
Code Information |
Item Number Lot Number: 1819-1020S K0ACFED; 1819-1220S K0CAEC4; 1832-2824S K0BF6C6; 1832-2828S K0CC742; 1832-3826S K0BF6D2; 1818-1115S K0B906C |
Recalling Firm/ Manufacturer |
Stryker GmbH Bohnackerweg 1 Selzach Switzerland
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For Additional Information Contact | Amina Crawford 201-831-5272 |
Manufacturer Reason for Recall | Incomplete seal on the Tyvek lid may compromise the sterility of the device |
FDA Determined Cause 2 | Packaging process control |
Action | Stryker notified consignee via UPS (with return receipt) on June 27, 2018 advising user of the problem, quarantine product and return. Complete and sign the Recall Notification Business Reply Form. Contact (201) 831-6693. |
Quantity in Commerce | 38 |
Distribution | US distribution to KY |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = HSB
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